FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
162361–162384 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 23, 1981
MEDTRONIC MODEL 2409
K812580 · DXY
Medtronic Vascular
Cardiovascular · 13d
Cleared Sep 23, 1981
SENSI-TECT
K812581 · JTZ
Uti-Tect, Inc.
Microbiology · 13d
Cleared Sep 23, 1981
CANCEL
K812582 · EXB
Bio Systems, Inc.
Gastroenterology & Urology · 13d
Cleared Sep 23, 1981
GER 540, GER 541 MANUAL BED
K812600 · FNJ
G.W. Healthcare, Inc.
General Hospital · 9d
Cleared Sep 21, 1981
SPECTACLE FRAMES
K810876 · HQZ
Fashionline Corp.
Ophthalmic · 174d
Cleared Sep 21, 1981
CAVITY VARNISH
K810913 · LBH
Dentsply Intl.
Dental · 168d
Cleared Sep 21, 1981
THE EMMETT IUD THREAD RETRIEVER
K811761 · HHF
Proto-Med, Inc.
Obstetrics & Gynecology · 91d
Cleared Sep 21, 1981
C-DAK DUO-FLUX ARTIFICIAL KIDNEY
K811830 · KDI
Cordis Corp.
Gastroenterology & Urology · 84d
Cleared Sep 21, 1981
STERI-TRACT
K811863 · KDJ
Rogo Ent.
Gastroenterology & Urology · 82d
Cleared Sep 21, 1981
FORAMATRON APICAL FORAMEN LOCATOR
K811995
Parker Laboratories, Inc.
Dental · 70d
Cleared Sep 21, 1981
OXYGEN MONITOR 140/141
K812040 · CCL
Medix Medical Electronics (U.S.A.), Inc.
Anesthesiology · 62d
Cleared Sep 21, 1981
PORTAPULSE
K812131 · DRT
Gavon, Inc.
Cardiovascular · 55d
Cleared Sep 21, 1981
AIRE-CUF TRACHEOSTOMY TUBE
K812163 · JOH
Bioana Surgical Instruments, Inc.
Anesthesiology · 54d
Cleared Sep 21, 1981
ENDOCERVICAL ASPIRATOR
K812175 · HFC
Fertility Instrumentation, Inc.
Obstetrics & Gynecology · 49d
Cleared Sep 21, 1981
UNITEK PALATAL BAR
K812239 · DYT
Unitek Corp.
Dental · 41d
Cleared Sep 21, 1981
NIVP MONITOR
K812259 · DXN
Datascope Corp.
Cardiovascular · 40d
Cleared Sep 21, 1981
LINGUAL BRACKET
K812300 · EJF
American Ormco
Dental · 38d
Cleared Sep 21, 1981
USCI TRANSTHORACIC TEMP. PACING ELECTROD
K812307 · LDF
C.R. Bard, Inc.
Cardiovascular · 35d
Cleared Sep 21, 1981
DEFIBRILLATOR/MONITOR
K812317 · LDD
Hewlett-Packard Co.
Cardiovascular · 35d
Cleared Sep 21, 1981
INTK-08 8 FRENCH INTRODUCER KIT W/SIDE
K812325 · DYB
Sorensen Research
Cardiovascular · 35d
Cleared Sep 21, 1981
ZEE EXTRICATION DEVICE
K812342 · IQF
Zee Medical Products Co., Inc.
Physical Medicine · 34d
Cleared Sep 21, 1981
PRECIOUS-METAL/PLASTIC ATTACH., AUXILL
K812360 · EGG
Zl-Microdent-Attachments
Dental · 32d
Cleared Sep 21, 1981
PRESET FLOWMETER
K812419 · CAX
Timeter Instrument Corp.
Anesthesiology · 28d
Cleared Sep 21, 1981
LENSINE EXTRA STRENGTH CLEANER
K812433 · HPX
CooperVision, Inc.
Ophthalmic · 27d